Digital disease management system

ABSTRACT

A method for improving the delivery of health care for patients. A first data signal being multimedia data which is indicative of a patient condition of a selected patient is input into a local computer. Clinical data, cost data and administrative data relating to the health of the selected patient are also input into the local computer. The first data signal is combined with the clinical data, cost data and administrative data to form a first patient information signal which is transmitted to a central computer. A predetermined disease stage is then assigned to the selected patient based on the first data signal. The disease stage is combined with the first patient information signal to form a second patient information signal. Then, a first array of risk factors is computed from a database containing a plurality of previously obtained individualized patient information records. A first predictive probability is then assigned to the selected patient based on the second patient information signal and the first array of risk factors. A first patient recommendation signal indicating one of the selected patient would benefit from immediate patient care and the selected patient would not benefit from immediate patient care is generated and then transmitted to the local computer. Both the second patient information signal and the first patient recommendation signal are transmitted to a regional computer in response to the first patient recommendation signal indicating that the selected patient requires immediate patient care.

CROSS-REFERENCE TO RELATED APPLICATIONS

Not applicable.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to devices and methods forimproving the delivery of patient care to patients, and moreparticularly, but not by way of limitation to devices and methods forimproving the delivery of patient care to patients wherein patientinformation relating to a selected patient is obtained at a localfacility system and is automatically transmitted to a regional facilitysystem in response to a first patient recommendation signal indicatingthat the selected patient would benefit from immediate patient care.

2. Brief Description of the Related Art

About sixteen million people in the United States are diabetics. It isknown in the art that diabetics are at risk for a disease referred to as"diabetic retinopathy". Diabetic retinopathy is an insidious diseasewhich if left untreated may cause blindness or serious vision loss.Because diabetic retinopathy does not cause pain or a change in theappearance of an afflicted individual's eye, diabetics afflicted withdiabetic retinopathy are typically unaware of a condition that threatenstheir vision. About 40,000 of the sixteen million diabetics in theUnited States may go blind each year because of unsuspected anduntreated diabetic retinopathy.

Although not all of these 40,000 diabetics can be effectively treated toprevent blindness even with regular screening eye exams, we estimatethat blindness could be prevented in about 50% of these 40,000 diabeticsif all of such diabetics were regularly screened for diabeticretinopathy. It should be noted that most general physicians are eitheruntrained or lack the necessary equipment to detect diabetic retinopathythrough an eye exam. Thus, diabetics must typically be examined by anoptometrist or an ophthalmologist, some of whom are retinal specialists,on a regular basis so that diabetic retinopathy can be detected in itsearly stages.

However, there are many barriers to health care such as time, money, andconvenience which prevent diabetics from receiving regular screeningeye-exams. For example, ophthalmologists and retinal specialists aretypically located in urban areas while diabetics are located in bothurban areas and rural areas. Thus, it has been difficult for thediabetics living in rural areas to obtain the necessary regular eyeexams from optometrists, ophthalmologists or retinal specialists becauseof the time and travel commitments needed for diabetics living in ruralareas. In addition, there are access problems involved in diabeticsreceiving regular screening eye exams even for those who live nearcomprehensive medical facilities. That is, diabetics should regularlyhave data collected about their eyes, their kidneys, their feet andtheir nervous system, for example. Currently, diabetics must have aseparate appointment with an optometrist or ophthalmologist to havetheir eyes examined, and a separate appointment with a nephrologist forkidney evaluation, and a separate appointment with a podiatrist to havetheir feet examined, and a separate appointment with a neurologist tohave their nervous system examined, etc. This creates problems for boththe diabetic patient and the health care providers in that it isinconvenient for the diabetic patient and difficult for each of thehealth care providers to keep each other informed. For these andpossibly other reasons It has been estimated that only about 50% ofdiabetics participate in regular screening eye exams.

In addition to the loss of sight of diabetics, unsuspected and untreateddiabetic retinopathy is also costly to society. Substantial savings onsociety which result from the screening for diabetic retinopathy havebeen predicted by several computer models. All of the models are basedon estimates of the annual cost of diagnosing and treating diabeticretinopathy, the annual cost of a year of blindness to the federalgovernment, the effectiveness of treatment and data depicting theprevalence, incidence and progression of the disease. Relying on the sumof annual Social Security benefits, Social Security insurance, taxlosses and payments from Medicare and Medicaid, the savings to societyper individual successfully enrolled in a long-term screening andtreatment program amounts to about $9571 per year.

To this end, a need has long existed for a disease management systemthat increases the accuracy and accessibility of health care while alsoreducing the expenses incurred thereby. It is to such a system that thepresent invention is directed.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING

FIG. 1 is a schematic, diagrammatic view of a digital disease managementsystem for improving the delivery of health care to patients which isoperating in accordance with the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The term "patient" as used herein alone or in combination with otherwords includes patients, clients, residents and consumers, and ingeneral means a person receiving health care.

The term "patient condition" as used herein means an abnormal ordiseased state of part of the patient's body. For example, the patientcondition can be diabetic retinopathy, dermatologic lesions, glaucoma orany other patient condition where clinical data parameters can beconverted into digital information and subsequently transmitted.

The term "health care provider" as used herein means a doctor, atechnician, a nurse or any other person who directly or indirectlydelivers health care to a patient. For example, if the patient conditionis diabetic retinopathy, the health care provider is typically anoptometrist or an ophthalmologist some of whom are retinal specialists.

The term "multimedia data" as used herein refers to any type of data orinformation which is indicative of any patient condition of a selectedpatient or patients. For example, the multimedia data can be composed ofstill or animated images, sounds, text, binary or analog data andcombinations thereof.

The terms "internet" and/or "signal path" refers to any suitablecommunication link which permits electronic communications. It should beunderstood that the term "internet" is not limited to "the Internet" orany other particular system or type of communication link. That is, theterms "internet" and/or "signal path" are intended only to refer to anysuitable communication system, including extra-computer system andintra-computer system communications. Examples of such communicationssystems include internal busses, local area networks, wide areanetworks, point-to-point shared and dedicated communications, infra-redlinks, microwave links, telephone links, CATV links, satellite and radiolinks and fibre-optic links. The terms "internet" and/or "signal path"can also refer to any suitable communication system for sending messagesbetween remote locations, directly or via a third party communicationprovider such as AT&T. In this instance, messages can be communicatedvia telephone or facsimile or computer synthesized voice telephonemessages with or without voice or tone recognition, or any othersuitable communications technique.

The terms "immediate" or "immediate patient care" as used hereintypically mean that the patient should receive patient care within 90days, and desirably within about 30 days of the current diagnosis whenthe disease condition is diabetic retinopathy. However, it should beunderstood that the terms "immediate" or "immediate patient care" asused herein can refer to any length of time from diagnosis so long asthe disease stage of the selected patient is not expected to progresssignificantly during this time period.

The terms "would not benefit from immediate patient care" as used hereinis not intended to mean that the selected patient does not benefit fromor need patient care entirely, but is intended to means that it isexpected, recommended or more cost effective that the selected patientnot receive treatment before the selected patient is screened again. Forexample, if it is expected that the patient condition of a selectedpatient may improve with no medical intervention or that the patientcondition will not progress significantly in a length of time greaterthan the period between regular screenings, the present system mayindicate that the selected patient "would not benefit from immediatepatient care" to indicate that no medical intervention should beinitiated before the next regular screening or that another screeningexam should be scheduled to more closely monitor the progression of thepatient condition.

It should be understood that each of the signal paths are shown anddescribed separately herein for the sole purpose of clearly illustratingthe information being communicated between each of the individualcomponents of the present invention. In operation, the signal paths maynot be separate signal paths but may be a single signal path.

Shown in FIG. 1 and indicated by the general reference numeral 10 is adigital disease management system for improving the delivery of healthcare to patients which is constructed in accordance with the presentinvention. The system 10 is provided with a plurality of local facilitysystems 12, a plurality of central facility systems 14 and a pluralityof regional facility systems 16. Only one of the local facility systems12, the central facility systems 14 and the regional facility systems 16are shown in FIG. 1 for purposes of clarity.

Each of the local facility systems 12 can be located at a localtreatment facility which is positioned anywhere that is convenient oraccessible for the selected patient, such as at the selected patient'shome or in a health care provider's office where a selected patientpresents to receive a check-up, examination, physical or the like. Thecentral facility systems 14 are typically located in a central readingcenter which is disposed remotely from the local facility system 12 andit is envisioned that the central facility systems 14 will be located ator near an urban area or medical research institute where it is likelythat medical specialists will reside. In one embodiment of the presentinvention, each of the central facility systems 14 will be adapted torecommend treatment concerning one or more different patient conditions.Each of the regional facility systems 16 are typically located in aregional treatment center. The regional treatment centers are typicallylocated in geographically disparate locations from the local facilitysystems 12 so that a centrally located regional treatment center islocated near some of the local facility systems 12 so that patientsinitially presenting at local facility systems 12 near the centrallylocated regional treatment center will be referred to the centrallylocated regional treatment center for purposes of convenience. Theregional treatment center can be any treatment center, such as adoctor's office or a hospital, where specialized equipment is used toprovide health care for a patient.

However, it should be understood that the local facility systems 12,regional facility systems 16 and the central facility systems 14 do nothave to be disposed in geographically disparate locations. For example,the local facility systems 12, regional facility systems 16 and thecentral facility systems 14 of the digital disease management system 10could be located within one building, such as a multispecialty clinic,where health care providers (such as ophthalmologists) have access tospecialized equipment (such as laser surgery capabilities) to providecomprehensive patient or health care to patients.

It should also be understood that although each of the local facilitysystems 12, regional facility systems 16 and central facility systems 14are described as separate entities herein, the hardware and software ofthe local facility systems 12, regional facility systems 16 and centralfacility systems 14 could be implemented as a single computer system ora plurality of interconnected computer systems, or a general purposecomputer system, or a distributed processing system, all of which arewell understood in the art.

The operation of the system 10 will be generally described herein withrespect to a specific patient condition referred to as "diabeticretinopathy". However, it will be understood that such operation appliesequally with respect to various other categories or types of patientconditions.

The local facility system 12 is provided with a local computer 18 whichis connected to a data input device 20, a digital input device 22 and anoutput device 24 as indicated by the signal paths 26, 28, and 30,respectively. The local computer 18 can be any suitable computer orpatient monitor. For example, the local computer 18 can be a MacintoshPowerPC which is obtainable from Apple Computers, Inc.

The local computer 18 receives a first data signal from the digitalinput device 22 via the signal path 28. The first data signal can be anydigital or multimedia data which is composed of clinical data and whichis indicative of any patient condition of a selected patient and thedigital input device 22 is any suitable device for obtaining suchdigital multimedia data. For example, if the patient condition isdiabetic retinopathy, the first data signal is typically a digitizedfundus image of the eye of the selected patient and the digital inputdevice 22 is a stereoscopic digital camera, such as a DCS digital camerawhich is obtainable from Kodak coupled with a fundus camera which isobtainable from Zeiss; and if the patient condition is glaucoma, thefirst data signal is typically digitized intraocular pressures and thedigital input device 22 is any suitable piece of equipment for obtainingand digitizing such intraocular pressures.

Once received by the local computer 18, the first data signal is outputover the signal path 30 to be received by the output device 24. Theoutput device 24 can be any suitable output device such as a printer ora monitor. If the output device 24 is a monitor the first data signalcan be displayed by the monitor as a patient "album" which displays rowsand columns of individual frames of data. A still image of the firstdata signal can be displayed as a thumbnail of the full resolution imagewhile a video clip of the first data signal can be represented by afrozen frame introducing the video clip with controls to play the videoclip.

The local computer 18 receives a second data signal relating to thehealth of the selected patient from the data input device 20. The seconddata signal received from the data input device 20 can be any desirablepatient data related to the selected patient, such as additionalclinical data, cost data and administrative data. The data input device20 can be a personal digital assistant, or a keyboard, for example.

The clinical data can be any clinical data relating to the health orpatient condition of the selected patient. For example, if the patientcondition is diabetic retinopathy, the clinical data can be visualacuity data, diastolic blood pressure data, amount of insulin data, typeof diet data, hemoglobin A1C levels data, age data, or data relating tolength of time in which the selected patient has had diabetes.

The cost data can be any cost data relating to the health or patientcondition of the selected patient. Typically, the cost data can begenerated using activity based costing parameters designated by thefinancially responsible organization's (for example an insurancecompany, health maintenance organization, integrated health deliverysystem, or a group practice) accounting system. For example, groups ofcost data can be direct costs, indirect costs and allocated costs, whilecategories of cost data include personnel costs, equipment costs,depreciation costs, general and administrative costs and supplies costs.

The administrative data can be any suitable administrative data relatingto the health or patient condition of the selected patient. For example,the administrative data can be patient demographics data, payor ofpatient expenses data, scheduling data, health system data and datarelating to which physicians are performing the management of thepatient condition of the selected patient.

The local computer 18 is loaded with a software program 32 whichreceives the first data signal and the second data signal and whichcombines the first data signal with the second data signal to form afirst patient information signal relating to the health of the selectedpatient. The first patient information signal is transmitted by thelocal computer 18 over a signal path 34 to be received by one of thecentral facility systems 14 which is capable of recommending treatmentrelating to the appropriate patient condition of the selected patient.If data is being collected at the local facility system 12 concerningmore than one type of patient condition or more than one type of testconcerning the same patient condition, the local facility system 12 maytransmit one first patient information signal relating to one of thetypes of patient conditions or test types to the appropriate centralfacility system 14 which is capable of recommending treatment for thatparticular patient condition or test type, and another first patientinformation signal to another appropriate central facility system 14which is capable of recommending treatment for that other particularpatient condition or test type. For example, the digital diseasemanagement system 10 may have one central facility system 14 which iscapable of recommending treatment for eye exams (diabetic retinopathy)and another central facility system 14 which is capable of recommendingtreatment for nervous systems. In this example, the selected patientpresents to one local facility system 12 and has eye exam data collectedand input into the local computer 18 and nervous system data collectedand input into the local computer 18. The local computer 18 would thentransmit one first patient information signal to one of the centralfacility systems 14 specializing in eye exams and another first patientinformation signal to another one of the central facility systems 14specializing in nervous systems, or the local facility system 12 wouldsend one first patient information signal containing informationregarding both of the patient conditions or test types to one centralfacility system 14 if that central facility system 14 is capable ofrecommending treatment for both patient conditions or test types.

It should be noted that the data input device 20 and the digital inputdevice 22 have been described herein as separate components to clarifythe types of data received by the local facility system 12. Thus, itshould be understood that in use, the local facility system 12 may beprovided with either one or both of the data input device 20 and thedigital input device 22.

Each central facility system 14 is provided with a central computer 36,a data analysis system 38 and a disease management logic module (DMLM)40. Although the central computer 36, data analysis system 38, and thedisease management logic module 40 are shown and described separatelyherein it should be understood that this is solely for purposes ofclarity. Thus, the central computer 36, data analysis system 38, and thedisease management logic module 40 can be one integrated system, or twoor more separate systems.

The first patient information signal is received and stored by thecentral computer 36 of the central facility system 14. The centralcomputer 36 can be any suitable computer, such as a "PowerPC Macintosh"which is obtainable from Apple computers. Once the first patientinformation signal is stored by the central computer 36, the firstpatient information signal is transmitted to the data analysis system 38via a signal path 42.

The data analysis system 38 receives and stores the first patientinformation signal, and in response thereto, the data analysis system 38assigns a predetermined disease stage to the selected patient based onthe data contained in the first data signal component of the firstpatient information signal. The disease stages are determined by theclinical features of the patient condition.

For example, if the patient condition is diabetic retinopathy, thespecific features of the clinical data (digital images of the eye) to beanalyzed include: macular edema (accumulation of fluid in the retina),microaneurysms, retinal hemorrhages, retinal exudates (accumulation oflipid and protein in the retina), cotton wool patches (areas of retinalinfarction), venous beading, intraretinal microvascular abnormalities(patterns of growth of irregular vessels in the retina),neovascularization (patterns of irregular vessels growing out of theretina), vitreous hemorrhage, retinal traction and retinal detachment.These patient characteristics allow classification of the patientcondition into the following disease stages.

    ______________________________________    Class 1      Normal or minimal nonproliferative                 diabetic retinopathy    Class 2      Nonproliferative diabetic                 retinopathy without macular edema    Class 3      Nonproliferative diabetic                 retinopathy with macular edema                 that is not clinically significant    Class 4      Nonproliferative diabetic                 retinopathy with clinically                 significant macular edema (CSME)    Class 5      Severe nonproliferative diabetic                 retinopathy (preproliferative)    Class 6      Non-high-risk proliferative                 diabetic retinopathy    Class 7      Non-high-risk proliferative                 diabetic retinopathy with CSME    Class 8      High-risk proliferative diabetic                 retinopathy    Class 9      High-risk proliferative diabetic                 retinopathy not amenable to                 photocoagulation    ______________________________________

Preferred Practice Pattern: Diabetic Retinopathy, American Academy ofOphthalmology, 1993.

The data analysis system 38 can be either manual or electronic and thesignal path 42 can be either manual or electronic. For example, if thedata analysis system 38 is manual, the data analysis system 38 maycomprise health care providers which view the first data signal (digitalimages of the eye) at the central computer 36 and then assign apredetermined disease stage to the selected patient based on the firstdata signal. However, if the data analysis system 38 is electronic, thedata analysis system 38 can comprise a computer loaded with softwarewhich analyzes the first data signal and then automatically assigns apredetermined disease stage to the selected patient based on the firstdata signal.

The disease stage assigned to the selected patient is input into thecentral computer 36 and combined with the first patient informationsignal to form a second patient information signal relating to thehealth of the selected patient. The second patient information signal istransmitted to the disease management logic module 40 via a signal path44. The signal path 44 can be either manual or electronic. For example,when the signal path 44 is manual, such signal path 44 may be peopletyping the disease stage and the first patient information signal into acomputer comprising the disease management logic module 40, and when thesignal path 44 is electronic, the signal path 44 may be a local areanetwork or the internal bus of the computer.

The disease management logic module 40 receives the second patientinformation signal. The disease management logic module 40 is providedwith a database 46 containing a plurality of previously obtainedindividualized patient information records. Each of the previouslyobtained patient information records desirably contain patientinformation relating to the patient care of an individual patient. Forexample, the patient information stored in each of the individualizedpatient information records could contain such information as theclinical data, cost data, administrative data, and disease stage datawhich is included in the second patient information signal; andtreatment parameter data which will be described hereinafter.

The disease management logic module 40 builds predictive models ofpatient condition outcomes and patient condition progressions utilizingthe information contained in the database 46. With respect to diabeticretinopathy, each of the individualized patient information recordscontain at least four parameters which have been linked as "comorbid"conditions and thereby affect the rate of progression of the disease orpatient condition. These four parameters are: 1) length of diabetes; 2)age of patient; 3) mean HbA1C levels; and 4) the presence ofmicroalbuminuric.

The disease management logic module 40 utilizes the informationcontained in the database 46 to categorize the selected patient into apopulation with similar characteristics and to quantify, compute orbuild a first array of relative risk factors from population statisticswhich are generally predictive of the progression of the patientcondition or disease of the selected patient over a given period of timegiven that selected patient's particular array of "comorbid" conditions.Once the first array of relative risk factors is computed, the diseasemanagement logic module 40 utilizes the first array of relative riskfactors and the disease stage assigned by the data analysis system 38 toassign a first predictive probability to the selected patient. The firstpredictive probability indicates whether or not the selected patient isinflicted with the patient condition, and if the selected patient isinflicted with the patient condition, the first predictive probabilityalso indicates the probability that the patient condition of theselected patient will advance or progress to a higher disease stage(e.g., from class 1 to class 2) within a relatively short period oftime.

In one embodiment, the disease management logic module 40 computes thefirst predictive probability by assigning the selected patient to a cellin a multidimensional transitional probability table containing thefirst array of relative risk factors and predetermined disease stages orexperiences of a population of patients having identical or similarcharacteristics as the selected patient.

The disease management logic module 40 then matches or compares theselected patient's patient characteristics (e.g. the disease stageassigned to the selected patient by the data analysis system 38, theadministrative data and the clinical data relating to the selectedpatient) with the population of patients (whose information is containedin the database) that share substantially similar patientcharacteristics to provide an indication (the first predictiveprobability) of the probability of the disease progression of thepatient condition of the selected patient.

The disease management logic module 40 then generates a first patientrecommendation signal based on the first predictive probability. Thefirst patient recommendation signal provides a predictive model of apreferred or recommended treatment for the selected patient's patientcondition. It should be noted that optimal treatment recommendationswill be generated in the first patient recommendation signal by thedisease management logic module 40 based on linking disease managementlogic module optimal management options with the cost of those optionsthrough predictive cost models. For example, if a patient has a nearthreshold condition (i.e. very close to needing laser surgery or is in ahigh risk group for vision loss) the cost of increasing screeningactivities in this patient (screening more often, for example) mayoffset the cost of potential vision loss or early surgery, and thereforebe a better way to manage the patient medically and economically.

The disease management logic module 40 is typically provided with bothelectronic and manual components. That is, the database 46 is typicallymaintained on a computer, such as the central computer 36, and the firstarray of relative risk factors, the predictive models and cost modelsare typically computed by the computer given the information discussedabove. However, the recommending of one of the predictive models andcost models in the first patient recommendation signal as therecommended treatment may be accomplished by a human health careprovider who recommends one of the predictive and cost models afterreviewing such models and then enters or inputs such recommendationsinto the computer.

The first patient recommendation signal typically includes the diseasestage assigned by the data analysis system 38 and the first predictiveprobability. Typically, the predictive model of the first patientrecommendation signal is in the form of a recommended timed schedulewhich indicates whether or not the selected patient would benefit fromimmediate patient care (medical intervention) or would not benefit fromimmediate patient care.

If the first predictive probability indicates that there is a highprobability that the patient condition will advance or progress to ahigher disease stage within a relatively short period of time, the firstpatient recommendation signal will indicate that the selected patientwould benefit from immediate patient care, such as laserphotocoagulation surgery, via a recommended schedule. In this case, thefirst patient recommendation schedule will indicate that an appointmentneeds to be scheduled for the selected patient at one of the regionaltreatment centers which can provide treatment concerning the patientcondition.

If, however, the first predictive probability indicates that theselected patient is not inflicted with the patient condition or thatthere is a low probability that the patient condition will advance orprogress to a higher disease stage within a relatively short period oftime, the first patient recommendation signal will indicate that theselected patient would not benefit from immediate patient care (surgery,for example) but needs to be screened again via a predetermined timeschedule of every three months, for example. In this case, the firstpatient recommendation signal will indicate that an appointment needs tobe scheduled for the selected patient to present again at the localfacility system 12 within the predetermined time.

For example, a 53 year male old patient with non-insulin dependentdiabetes mellitus (NIDDM) and uncontrolled hypertension (mean diastolicblood pressure of 120) and three consecutive urinalyses demonstratingmicroalbuminuric over the last three months with a 20 year history ofdiabetes and with nonproliferative diabetic retinopathy andnon-clinically significant macular edema (class 3 disease stage)presents on initial evaluation to the digital disease management system10. In this case, the first predictive probability may demonstrate a0.5% chance of progression to disease stage 4 in three months, a 7.0%chance of progression to disease stage 4 in six months, and a 25.0%chance of progression to disease stage 4 in nine months. Given theseprobabilities, the first patient recommendation signal would recommendthat the selected patient would not benefit from immediate patient carebut needs to be screened again in three months. If the selected patientpresents with similar findings at the three month follow-up visit asimilar risk and patient recommendation would be allocated to theselected patient. However, if the selected patient had increased to theclass 4 disease stage then the first patient recommendation signal wouldindicate that the selected patient would benefit from immediate patientcare so that laser surgery could be delivered before significant visualloss occurs. The specific known risks or comorbid factors contributingto disease progression are her age, length of time the patient has haddiabetes, elevated blood pressure, and early evidence of kidney problems(albumin in the urine).

It should be noted that the database 46 will be initially provided withan incomplete array of transitional probabilities because such database46 will be provided with information obtained through the existingglobal experience as documented in multiple clinical trials. However, byincorporating the actual experiences of patients, such as the selectedpatient, which are managed by the system 10 into the database 46, therisk probabilities such as the first array of relative risk factorsand/or the array of transitional probabilities will be progressivelyinfluenced by actual experience from within the system 10. Thus, thepatient information such as the information contained in the secondinformation signal is used to update the database 46.

The central facility system 14 can be programmed to provide anotification to the selected patient if the selected patient does notreceive another screening exam at the appropriate time. For example,assume that the local facility system 12 is located at the selectedpatient's home and the selected patient is supposed to be examined orprovide care for himself once a day and the data collected by suchexamination (the first patient information signal) is provided to one ofthe central facility systems 14 by the local facility system 12 on adaily basis. In this case, if the one central facility system 14 doesnot receive information from the local facility system 12 after apredetermined time of two days, for example, the central facility system14 may output a notification signal to alert a health care provider thatthe selected patient is not receiving daily exams.

The disease management logic module 40 transmits the first patientrecommendation signal to the central computer 36 via a signal path 48.The central computer 36 receives the first patient recommendationsignal, and in response thereto, the central computer 36 transmits thefirst patient recommendation signal to the local computer 18 via asignal path 50.

The local computer 18 receives the first patient recommendation signal,and in response thereto, the local computer 18 outputs the first patientrecommendation signal to the output device 24 so that the first patientrecommendation signal is perceivable by a health care provider.

In response to the first patient recommendation signal indicating thatthe selected patient would benefit from immediate patient care, thecentral computer 36 automatically or manually transmits a third patientinformation signal to a regional computer 52 located at the regionalfacility system 16 via a signal path 54. The third patient informationsignal is typically indicative of both the second patient informationsignal and the first patient recommendation signal. However, it shouldbe understood that the third patient information signal can be a signalnotifying the regional facility system 16 that information is availableto such regional facility system 16 so that the regional computer 52 canretrieve the information contained in the second patient informationsignal and/or the first patient recommendation signal when appropriateso that such information can be utilized in the treatment of theselected patient. In addition, it should be understood that anappointment schedule of the selected patient may be either transmittedto or made available to the regional facility system 16 by the centralfacility system 14.

The regional computer 52 receives the third patient information signal,and in response thereto, the regional computer 52 outputs the thirdpatient information signal to an output device 56 via a signal path 58such that the information relating to the selected patient which iscontained within the third patient information signal is perceivable bya health care provider located at the regional treatment center so thatthe information contained in the third patient information signal can beutilized by the health care provider to render individualized patientcare (e.g. laser photocoagulation) to the selected patient in accordancewith the third patient information signal. The regional computer 52 canbe any suitable computer, such as a Macintosh PowerPC which isobtainable from Apple Computers, Inc.

Please note that at the time of treatment, the patient diagnosis isalready established (thus, no screening exam is required), and thediagnostic information (e.g. digital photographs and clinical data) isavailable to the health care provider so that the treatment of theselected patient can proceed efficiently.

Once health or patient care is rendered to the selected patient,post-operative patient care data is input into the regional computer inthe form of a third data signal transmitted by a digital input device 60via a signal path 62. For example, if the patient condition is diabeticretinopathy, the third data signal is typically a digitized fundus imageof the eye of the patient photographed after patient care has beenrendered to the selected patient and the digital input device 60 is astereoscopic digital camera, such as a DCS digital camera which isobtainable from Kodak coupled to a fundus camera which is obtainablefrom Zeiss; and if the patient condition is glaucoma, the third datasignal is typically digitized intraocular pressures and the digitalinput device 60 is any appropriate input device which is capable ofobtaining and digitizing such pressures.

Once received by the regional computer 52, the third data signal isoutput over the signal path to be received by the output device 56. Theoutput device 56 can be any suitable output device such as a printer ora monitor. If the output device 56 is a monitor the third data signalcan be displayed by the monitor as a patient "album" which displays rowsand columns of individual frames of data. A still image of the firstdata signal can be displayed as a thumbnail of the full resolution imagewhile a video clip of the first data signal can be represented by afrozen frame introducing the video clip with controls to play the videoclip.

The regional computer 52 receives a fourth data signal relating to thepost-treatment health of the selected patient from a data input device64 via a signal path 66. The fourth data signal received from the datainput device 64 can be any desirable post-treatment or pre-treatmentpatient related data, such as treatment parameters data and follow-uprecommendations data. With respect to the patient condition beingdiabetic retinopathy, the treatment parameters typically include: date,diagnosis, eye treated, number of laser applications, laser spot size,laser power duration, laser wavelength, method of anesthesia,complications and area(s) of treatment.

The third data signal and the fourth data signal are combined by theregional computer 52 to form a fourth patient information signalrelating to the post-treatment health of the selected patient. Thefourth patient information signal is transmitted to the central computer36 from the regional computer 52 via a signal path 68.

It should be noted that the data input device 64 and the digital inputdevice 60 have been described herein as separate components to clarifythe types of data received by the regional treatment system 16. Itshould be understood that in use, the regional treatment system 16 maybe provided with either one or both of the digital input device 60 andthe data input device 64.

The fourth patient information signal is received by the centralcomputer 36, and in response thereto, the central computer 36 transmitsthe fourth patient information signal to the disease management logicmodule 40 via a signal path 70. The fourth patient information signal isreceived by the disease management logic module 40.

The disease management logic module 40 then utilizes the treatmentparameter data contained in the fourth patient information signal toupdate the database 46 of the disease management logic module 40 so thatexperiences or information learned from the rendering of health orpatient care to the selected patient can be utilized by the diseasemanagement logic module 40 as feedback to track the progress of thepatient condition of the selected patient so that the predictiveprobabilities determined by the disease management logic module 40 canbecome increasingly more accurate. In other words, the database 46 isupdated so that the experiences, treatment recommendations and progressof the selected patient can be used to provide predictive probabilitiesfor other patients.

Once the database 46 of the disease management logic module 40 isupdated, the updated database 46 is utilized by the disease managementlogic module 40 to compute or build a second array of relative riskfactors which are generally predictive of the progression of the patientcondition or disease of a patient. Once the second array of relativerisk factors is computed, the disease management logic module 40utilizes the second array of relative risk factors, the disease stageassigned by the data analysis system 38 and the clinical data containedin the fourth patient information signal to assign a second predictiveprobability to the selected patient in a similar manner as the firstpredictive probability was assigned to the selected patient ashereinbefore described. That is, the second predictive probabilityindicates whether or not the selected patient is inflicted with thepatient condition, and if the selected patient is inflicted with thepatient condition, the second predictive probability also indicates theprobability that the patient condition of the selected patient willadvance or progress to a higher disease stage (e.g., from class 1 toclass 2) within a relatively short period of time.

In other words, the disease management logic module 40 matches orcompares the selected patient's patient characteristics (the diseasestage assigned to the selected patient by the data analysis system 38and the clinical data relating to the selected patient) with apopulation of patients (whose information is contained in the database)that share substantially similar patient characteristics to provide anindication (the second predictive probability) of the probability of thedisease progression of the patient condition of the selected patient.

The disease management logic module 40 then generates a second patientrecommendation signal based on the second predictive probability in asimilar manner as the first patient recommendation signal was generated,as hereinbefore described. That is, the second patient recommendationsignal provides a predictive model of a preferred or recommendedtreatment for the selected patient's patient condition. It should benoted that optimal treatment recommendations will be generated in thesecond patient recommendation signal by the disease management logicmodule 40 based on linking disease management logic module optimalmanagement options with the cost of those options through predictivecost models.

The second patient recommendation signal typically includes the diseasestage assigned by the data analysis system 38 and the second predictiveprobability. Typically, the predictive model of the second patientrecommendation signal is in the form of a recommended timed schedulewhich indicates whether or not the selected patient would benefit fromimmediate patient care (medical intervention) or would not benefit fromimmediate patient care.

If the second predictive probability indicates that there is a highprobability that the patient condition will advance or progress to ahigher disease stage within a relatively short period of time, thesecond patient recommendation signal will indicate that the selectedpatient would benefit from immediate patient care, such as laserphotocoagulation surgery, via a recommended schedule. In this case, thesecond patient recommendation schedule will indicate that an appointmentneeds to be scheduled for the selected patient at one of the regionaltreatment centers.

If, however, the second predictive probability indicates that theselected patient is not inflicted with the patient condition or thatthere is a low probability that the patient condition will advance orprogress to a higher disease stage within a relatively short period oftime, the second patient recommendation signal will indicate that theselected patient would not benefit from immediate patient care (surgery,for example) but needs to be screened again via a predetermined timeschedule of every three months, for example. In this case, the secondpatient recommendation signal will indicate that an appointment needs tobe scheduled for the selected patient to present again at the localfacility system 12 within the predetermined time.

The disease management logic module 40 transmits the second patientrecommendation signal to the central computer 36 via a signal path 72.The central computer 36 receives the second patient recommendationsignal, and in response thereto, the central computer 36 transmits thesecond patient recommendation signal to the local computer 18.

The local computer 18 receives the second patient recommendation signal,and in response thereto, the local computer 18 outputs the secondpatient recommendation signal to the output device 24 so that the secondpatient recommendation signal is perceivable by a patient care provider.

While only one cycle of each process or method disclosed herein has beendescribed in detail, it should be understood that the processes ormethods disclosed herein are designed to be repeated for any one of anumber of predetermined times so that the digital disease managementsystem 10 can be utilized continuously by patients and health careproviders as provided herein.

Changes may be made in the steps or the sequence of steps of the methodsdescribed herein without departing from the spirit and the scope of theinvention as defined in the following claims.

What is claimed is:
 1. A method for improving the delivery of health care for patients, comprising the steps of:a. receiving a first patient information signal by a central facility computer, the first patient information signal being related to a selected patient and composed of multimedia data selected from the group comprising clinical data, cost data, administrative data, and combinations thereof; b. assigning one of a plurality of predetermined disease stages to the selected patient based on information contained in the first patient information signal; c. inputting the predetermined disease stage into the central facility computer; d. assigning a first predictive probability to the selected patient by the central facility computer based on at least one of the first patient information signal, the disease stage and a first array of risk factors, the first array of risk factors being computed from a database containing a plurality of previously obtained individualized patient information records, each of the patient information records containing patient information relating to the patient care of an individual patient; e. inputting the first predictive probability into the central facility computer; f. generating a first patient recommendation signal by the central facility computer, the first patient recommendation signal indicating a recommendation selected from the group of recommendations comprising the selected patient would benefit from immediate patient care and the selected patient would not benefit from immediate patient care; g. transmitting the first patient recommendation signal to a local computer; h. receiving the first patient recommendation signal by the local computer; and i. transmitting, from the central facility computer to a regional computer located at a regional treatment center, a second patient information signal in response to the first patient recommendation signal indicating that the selected patient would benefit from immediate patient care.
 2. A method, as recited in claim 1, further comprising the step of:j. rendering individualized patient care to the selected patient at the regional treatment center in accordance with the information contained in the second patient information signal.
 3. A method, as recited in claim 2, further comprising the steps of:k. transmitting, by the regional computer, a third patient information signal relating to the post-treatment health of the selected patient to the central facility, the third patient information signal being multimedia data which is selected from the group comprising clinical data, cost data, treatment parameter data, administrative data, and combinations thereof; l. receiving the third patient information signal by the central facility computer; and m. updating the database with at least the treatment parameter data contained within the third patient information signal.
 4. A method, as recited in claim 3, further comprising the steps of:n. computing a second array of risk factors from the updated database; o. assigning a second predictive probability to the selected patient based on the information contained in the third patient information signal and the second array of risk factors; p. inputting the second predictive probability into the central facility computer; and q. generating, by the central facility computer, a second patient recommendation signal indicating a recommendation selected from the group of recommendations comprising the selected patient would benefit from immediate patient care and the selected patient would not benefit from immediate patient care.
 5. A method, as recited in claim 1, wherein the first patient information signal is transmitted by the local computer to the central facility computer.
 6. A method for improving the delivery of health care for patients, comprising the steps of:a. receiving a first patient information signal by a central facility computer, the first patient information signal being related to a selected patient and composed of multimedia data selected from the group comprising clinical data, cost data, administrative data, and combinations thereof; b. assigning one of a plurality of predetermined disease stages to the selected patient based on information contained in the first patient information signal; c. inputting the predetermined disease stage into the central facility computer; d. assigning a first predictive probability to the selected patient by the central facility computer based on at least one of the first patient information signal, the disease stage and a first array of risk factors, the first array of risk factors being computed from a database containing a plurality of previously obtained individualized patient information records, each of the patient information records containing patient information relating to the patient care of an individual patient; e. inputting the first predictive probability into the central facility computer; f. generating a first patient recommendation signal by the central facility computer, the first patient recommendation signal indicating a recommendation selected from the group of recommendations comprising the selected patient would benefit from immediate patient care and the selected patient would not benefit from immediate patient care; g. transmitting the first patient recommendation signal to a local computer; h. receiving the first patient recommendation signal by the local computer; and i. transmitting, from at least one of the central facility computer and the local computer to a regional computer located at a regional treatment center, a second patient information signal in response to the first patient recommendation signal indicating that the selected patient would benefit from immediate patient care.
 7. A method, as recited in claim 6, further comprising the step of:j. rendering individualized patient care to the selected patient at the regional treatment center in accordance with the information contained in the second patient information signal.
 8. A method, as recited in claim 7, further comprising the steps of:k. transmitting, by the regional computer, a third patient information signal relating to the post-treatment health of the selected patient to the central facility computer, the third patient information signal being multimedia data which is selected from the group comprising clinical data, cost data, treatment parameter data, administrative data, and combinations thereof; l. receiving the third patient information signal by the central facility computer; and m. updating the database with at least the treatment parameter data contained within the third patient information signal.
 9. A method, as recited in claim 8, further comprising the steps of:n. computing a second array of risk factors from the updated database; o. assigning a second predictive probability to the selected patient based on the information contained in the third patient information signal and the second array of risk factors; p. inputting the second predictive probability into the central facility computer; and q. generating a second patient recommendation signal indicating a recommendation selected from the group of recommendations comprising the selected patient would benefit from immediate patient care and the selected patient would not benefit from immediate patient care.
 10. A method, as recited in claim 6, wherein the first patient information signal is transmitted by the local computer to the central facility computer.
 11. A method for improving the delivery of health care for patients, comprising the steps of:a. receiving a first patient information signal relating to the health of a selected patient by a central facility computer, the first patient information signal being composed of multimedia data selected from the group comprising clinical data, cost data, administrative data, and combinations thereof, the clinical data being selected from the group of data comprising images of the selected patient's eye, visual acuity, diastolic blood pressure, amount of insulin, type of diet, hemoglobin A1C levels, age, and length of time in which the selected patient has had diabetes, the cost data being selected from the group of data comprising personnel cost, equipment cost, depreciation cost, general and administrative costs and supplies cost, the administrative data being selected from the group of data comprising demographics, payer, scheduling, health system and which specialty physicians are managing the patient's diabetes and complications of diabetes; b. assigning one of a plurality of predetermined disease stages to the selected patient based on the clinical data contained in the first patient information signal; c. inputting the predetermined disease stage into the central facility computer; d. computing a first array of risk factors from a database containing a plurality of previously obtained individualized patient information records, each of the patient information records containing patient information relating to the patient care of an individual patient; e. assigning a first predictive probability to the selected patient based on the information contained in the first patient information signal, the predetermined disease stage and the first array of risk factors; f. inputting the first predictive probability into the central facility computer; g. generating a first patient recommendation signal by the central facility computer, the first patient recommendation signal indicating a recommendation selected from the group of recommendations comprising the selected patient would benefit from immediate patient care and the selected patient would not benefit from immediate patient care; h. transmitting the first patient recommendation signal to a local computer located at a local treatment facility; i. receiving the first patient recommendation signal by the local computer; and j. transmitting a second patient information signal to a regional computer located at a regional treatment center in response to the first patient recommendation signal indicating that the selected patient would benefit from immediate patient care.
 12. A method, as recited in claim 11, wherein the second patient information signal is composed of the first patient information signal, the predetermined disease stage and the first patient recommendation signal and wherein the method further comprises the step of:k. rendering individualized patient care to the eye of the selected patient at the regional treatment center in accordance with the information contained in the second patient information signal.
 13. A method, as recited in claim 12, further comprising the steps of:l. transmitting, by the regional computer, a third patient information signal to the central facility computer, the third patient information signal being composed of multimedia data selected from the group comprising clinical data and treatment parameter data relating to the post-treatment health of the selected patient, the treatment parameter data being selected from the group of data comprising date, diagnosis, eye treated, number of laser applications, laser spot size, laser power duration, laser wavelength, method of anesthesia, complications, area(s) of treatment, and combinations thereof; m. receiving the third patient information signal by the central facility computer; and n. updating the database with at least some of the treatment parameter data contained within the third patient information signal.
 14. A method, as recited in claim 13, further comprising the steps of:o. computing a second array of risk factors from the updated database by the central facility computer; p. assigning a second predictive probability to the selected patient based on the third patient information signal and the second array of risk factors; q. inputting the second predictive probability into the central facility computer; and r. generating a second patient recommendation signal by the central facility computer, the second patient recommendation signal indicating a recommendation selected from a group of recommendations comprising the selected patient would benefit from immediate patient care and the selected patient would not benefit from immediate patient care.
 15. A method, as recited in claim 11, further including the step of:s. photographing the eye of the selected patient with a stereoscopic digital camera to provide a digitized image of the eye of the selected patient.
 16. A method for improving the delivery of health care delivered to a selected patient, comprising the steps of:a. photographing, at a local facility, the eye of a selected patient with a stereoscopic digital camera to provide clinical data composed of a first digitized image of the eye of the selected patient; b. inputting, automatically, the first digitized image of the eye of the selected patient into a local computer which is located at the local facility; c. inputting cost data, administrative data and additional clinical data relating to the health of the selected patient and the treatment of diabetic retinopathy into the local computer, the clinical data being selected from the group of data comprising visual acuity, diastolic blood pressure, amount of insulin, type of diet, hemoglobin A1C levels, age, length of time in which the selected patient has had diabetes, and combinations thereof, the cost data being selected from the group of data comprising personnel cost, equipment cost, depreciation cost, general and administrative costs, supplies cost, and combinations thereof, the administrative data being selected from the group of data comprising demographics, payer, scheduling, health system and which specialty physicians are managing the patient's diabetes, complications of diabetes, and combinations thereof; d. combining, by the local computer, the first digitized image of the eye of the selected patient with the clinical data, cost data and administrative data to form a first patient information signal relating to the treatment of diabetic retinopathy of the selected patient; e. transmitting, by the local computer, the first patient information signal to a central computer which is located at a central information center, the central information center being located remotely from the local computer; f. receiving and storing, by the central computer, the first patient information signal; g. transmitting, by the central computer, the first patient information signal to a data analysis system; h. receiving, by the data analysis system, the first patient information signal; i. assigning, by the data analysis system, a predetermined disease stage relating to diabetic retinopathy to the selected patient based on the first digitized image of the eye; j. combining the disease stage with the first patient information signal to form a second patient information signal; k. transmitting the second patient information signal to a disease management logic module; l. receiving by the disease management logic module the second patient information signal; m. computing a first array of risk factors by the disease management logic module, the first array of risk factors being selected from the group of risk factors comprising age, length of diabetes, diastolic blood pressure, HbA1C levels and combinations thereof from a database containing a plurality of previously obtained individualized patient information records, each of the patient information records containing patient information relating to the patient care of diabetic retinopathy of an individual patient; n. assigning a first predictive probability to the selected patient based on the second patient information signal and the first array of risk factors; o. inputting the first predictive probability into the disease management logic module; p. generating a first patient recommendation signal based on the first predictive probability by the disease management logic module, the first patient recommendation signal including the disease stage assigned by the data analysis system, the first predictive probability and a predictive model of an individualized preferred treatment of diabetic retinopathy, the preferred treatment indicating a recommendation selected from a group of recommendations comprising the selected patient would benefit from immediate patient care and the selected patient would not benefit from immediate patient care; q. transmitting the first patient recommendation signal from the disease management logic module to the central computer; r. receiving the first patient recommendation signal by the central computer; s. transmitting the first patient recommendation signal to the local computer; t. receiving the first patient recommendation signal by the local computer; u. outputting via the local computer the first patient recommendation signal to an output device such that the first patient recommendation signal is perceivable by a patient care provider; v. transmitting, automatically, a third patient information signal indicative of both the second patient information signal and the first patient recommendation signal by the central computer to a regional computer located at a regional treatment center in response to the first patient recommendation signal indicating that the selected patient would benefit from immediate patient care, the regional treatment center being located remotely from the local facility; w. receiving the third patient information signal by the regional computer; x. outputting via the regional computer the third patient information signal to an output device such that the information relating to the selected patient which is contained within the third patient information signal is perceivable by a patient care provider located at the regional treatment center; y. rendering individualized patient care to the selected patient in accordance with the third patient information signal; z. photographing, at the regional treatment center, the eye of the selected patient with a stereoscopic digital camera after care has been rendered to the selected patient to provide a second digitized image of the eye of the selected patient; aa. inputting, automatically, the second digitized image of the eye of the selected patient into the regional computer; ab. inputting treatment parameters relating to the post-treatment health of the selected patient into the local computer, the treatment parameters being selected from a group comprising date, diagnosis, eye treated, number of laser applications, laser spot size, laser power duration, laser wavelength, method of anesthesia, complications, area(s) of treatment, and combinations thereof; ac. combining, by the local computer, the second digitized image of the eye of the selected patient with the treatment parameter data to form a fourth patient information signal; ad. transmitting the fourth patient information signal to the central computer from the regional computer; ae. receiving the fourth patient information signal by the central computer; af. transmitting the fourth patient information signal to the disease management logic module; ag. receiving the fourth patient information signal by the disease management logic module; ah. updating the database of the disease management logic module with the clinical data contained within the fourth patient information signal; ai. computing a second array of risk factors from the updated database; aj. assigning a second predictive probability to the selected patient based on the fourth patient information signal and the second array of risk factors; ak. inputting the second predictive probability into the disease management logic module; al. generating a second patient recommendation signal indicating a recommendation selected from a group of recommendations consisting of the selected patient would benefit from follow up patient care and the selected patient would not benefit from follow up patient care; am. transmitting the second patient recommendation signal from the disease management logic module to the central computer; an. receiving the second patient recommendation signal by the central computer; and ao. transmitting the second patient recommendation signal to the local computer. 